Senior Post Market Surveillance Manager - Medical Devices - Collaborative Environment

Our client are a leading designer, manufacturer and marketer of innovation used in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea.

Driven by a strong sense of purpose, they are working to improve patient care and outcomes through inspired and world-leading healthcare solutions. Their medical devices and technologies help clinicians deliver the best possible patient care. 

On their behalf, Scitex are currently seeking a proven Senior Post Market Surveillance Manager to join their operation in an exciting team leadership capacity. This is a newly created position.


Role snapshot

To plan, lead and drive forward the corporate Post Market Surveillance function to achieve business objectives and provide the organisation with a competitive
advantage. Success in the role will be enabled by the proactive management of risk in a timely manner, while ensuring compliance to the QMS and regulatory requirements.


Responsibilities of the role

•  Lead, manage & develop employees to ensure a highly motivated and performing team who are able to successfully deliver results.
• Develop, deploy, and execute strategies that enable the achievement of business objectives and provide a competitive advantage.
• Define and agree on the priority of quality needs. Plan activities and allocate quality resources accordingly to ensure business needs are met and applicable business plan objectives are achieved.
• Develop and report on post market surveillance performance, identifying any business risks and opportunities for process improvement.
• Escalate and support the business navigating the proactive management of risk for product in field in a timely manner and monitor compliance to the QMS and regulatory requirements to limit regulatory risk.
• Develop and maintain relationships with networks, regulatory authorities, agencies and industry trade groups to ensure continuous improvement and provide regulatory and market context in order to provide a competitive advantage.
• Ensure compliance with applicable post market surveillance procedures, the F&P QMS and international regulatory requirements in order to limit regulatory risk, including timely and appropriate reporting to regulatory authorities to maintain regulatory compliance.
• Monitor the external regulatory and industry environment, identifying and implementing changes which may impact on product performance, safety and the QMS.

What you need to bring

• Extensive knowledge of medical device regulations (specifically, the US & EU).
• Experience interacting with Regulatory Authorities, specifically FDA
• Negotiating and influencing skills.
• Proven leadership ability to develop and retain highly experienced quality professionals and high potential.
• Broad exposure to all parts of a Medical Device Quality Management System.
• In-depth understanding and proven application of risk management in post market surveillance.
• Financial management skills and understanding of the financial and business impact of quality strategies.
• Conflict resolution skills.

And in return you will

• Join a leading New Zealand organisation making significant impact across the world.
• Receive a competitive package and relocation support offered (where needed).
• Work in a dynamic and progressive campus, based in East Tamaki, Auckland.

How to Apply:

Click APPLY now or contact Gareth Robertson on +64 9 200 3127 or [email protected] for a confidential discussion.